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Treatment of restenosis

Inactive Publication Date: 2004-04-13
YISSUM RES DEV CO OF THE HEBREW UNIV OF JERUSALEM LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The results show that treatment by clodronate-containing liposomes significantly reduces neointimal formation following balloon-injury in both rat and rabbit models. There were neither apparent systemic and local side effects nor any effects on somatic growth. It should be noted that although BP are known as affecting bone, no effects on the bone nor on calcium and phosphorus levels in bone and blood were observed, following treatment with liposomal preparation of clodronate.

Problems solved by technology

However, revascularization induces thrombosis and neointimal hyperplasia, which in turn cause restenosis in a substantial proportion of coronary arteries after successful balloon angioplasty and in aortacoronary saphenous vein bypass graft and other coronary grafts.
However, very often restenosis occurs notwithstanding the presence of the stent within the blood vessel.

Method used

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  • Treatment of restenosis

Examples

Experimental program
Comparison scheme
Effect test

example 1

Materials and Methods

Liposomes of Clodronate

Stock solutions of clodronate were prepared by dissolving the drug in deionized water at a concentration of 0.11 M, pH=7.

Liposome Preparation

38.9 mg of distearoylphosphatidylglycerol (DSPG), 118.5 mg of distearoylphosphatidylcholine (DSPC) and 38.7 mg of cholesterol were accurately weighed and dissolved in 20 ml of chloroform: methanol (9:1) in a round bottom vial. The vial was gently warmed. The solvent was then evaporated in rotavapor. 20 mls of hydrated diisopropylether were then added and the vial was put into a water bath until the contents were dissolved. 8 mls of the clodronate solution prepared as described above, were then added, and the solution was sonicated at 55 C for a period of 45 mins. The organic phase was then evaporated in rotavapor (55 C, 100 rpm). Similarly, other drug-containing liposomes can be prepared.

Purification of Prepared Liposomes

A Sephadex gel was prepared by dissolving 2.6 gr of Sephadex G-50 in 40 mls of wa...

example 2

Materials and Methods

The antirestenotic effects of liposomal clodronate injections were studied in the balloon-injured rat and atherosclerotic rabbit carotid arterial models. The rats were treated by clodronate-containing liposomes, empty liposomes (control), and clodronate in solution (additional control). The dose of clodronate injected was 1.5 and 15 mg / kg administered one day before procedure (-1) and / or on day 6 (+6) post injury. The rabbits (following 30 days of atherosclerotic diet) were treated one day prior to balloon angioplasty by liposomal clodronate (10 mg / kg). The lumen, neointimal, medial and vessel areas and volumes were measured in the treated and control animal groups by digital planimetry of histological sections, at 14 and 30 days post injury in the rat and rabbit models, respectively.

Results

The results are shown in the following Table 1.

As can be seen, no significant differences were found between treatments with empty liposomes, and free clodronate in solution ...

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Abstract

Bisphosphonate (BP), pyrophosphate (PP) a complex of BP or PP, a polymer of BP or PP or pharmaceutically acceptable salt or ester thereof, are used for the prevention or treatment of vascular restenosis.

Description

The present invention is concerned with compositions capable of preventing, inhibiting or reducing restenosis (sometimes referred to in the art as "accelerated arteriosclerosis" and "post-angioplasty narrowing").PRIOR ARTThe following references are considered to be pertinent for the purpose of understanding the background of the present invention.1. Waller, B. F., Orr, C. M, VanTassel J., et al. Clin-Cardiol. 20(2):153-60, (1997).2. Anderson, W. D, King, S. Br., Curr-Opin-Cardiol., 11(6):583-90, (1996).3. Moorman, D. L., Kruyer, W. B., Jackson, W. G., Aviat-Space-Environ-Med. 67(10):990-6, (1996).4. Laurent S, Vanhoutte P, Cavero I, et al., Fundam. Clin. Pharmacol., 10(3):243-57, (1996).5. Walsh, K., Perlman, Semin-Interv-Cardiol., 1(3):173-9, (1996).6. Schwartz, R. S., Semin-Interv-Cardiol., 2(2):83-8, (1997).7. Allaire, E, Clowes, A. W. Ann. Thorac. Surg., 63:582-591, (1997).8. Hamon. M., Bauters, C., McFadden, E. P, et al., Eur. Heart J., 16:33s-48s, (1995).9. Gottsauner-Wolf, M...

Claims

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Application Information

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IPC IPC(8): A61K31/66A61K9/127A61K31/662A61P9/00A61P9/10
CPCA61K31/66A61K31/662A61P43/00A61P9/00A61P9/10A61K31/663
Inventor GOLOMB, GERSONDANENBERG, HAIM
Owner YISSUM RES DEV CO OF THE HEBREW UNIV OF JERUSALEM LTD
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